A Prospective, Single Arm, Post Market Clinical Follow-up (PMCF) Study to Evaluate the Safety and Performance of Hand Plate System - Nil

Auxein Medical Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年5月27日

研究概览

暂无简介。

•1 Both male and female above 18 years to 65 years
•2 Patients presenting to Orthopaedic emergency or OPD with Hand Fracture which need internal fixation will be included in the study

•1 Any past or present evidence of infection of the treated joint
•2 Physical conditions that would eliminate or tend to eliminate adequate implant support or delayed healing viz blood supply limitations poor skin quality previous or active infections sepsis metabolic diseases etc
•3 Signs of any local inflammation
•4 Patient susceptibility to allergic reaction to the components of the alloy the implant is manufactured from
•5 Mental or neurological conditions which tend to pre empt the patients ability or willingness to restrict activities during the healing period viz Parkinsons disease chronic alcoholism Charcots joints drug abuse mental illness patient noncompliance etc
•6 Patients having inadequate tissue coverage over the operative site
•7 Patient having Foreign body sensitivity
•8 Patient with compromised skin
•9 Severe osteopenia and or osteoporosis or the presence of marked or rapid bone absorption metabolic bone disease cancer or any other tumor like condition of the bone which may compromise fixation
•10 Patient who is pregnant or intends to become pregnant during the study

发起方

Auxein Medical Pvt Ltd